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Small Bioactive Molecules in Early COPD Diseases

Role of Small Bioactive Molecules in the Progression of Early COPD Diseases

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04950023
Enrollment
550
Registered
2021-07-02
Start date
2021-05-11
Completion date
2024-05-11
Last updated
2021-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Brief summary

To study the predictors contribute to the progression of COPD by follow-up of patients with early COPD and analyze their changes in bioactive molecular, exhaled gas, CT image, lung function, patient's symptoms and life quality.

Detailed description

A research found that nearly 40% of patients with chronic respiratory symptoms who showed significant airway inflammation (airway wall thickening and/or lung structure destruction (emphysema) on chest CT had advanced COPD within 5 years, although their current lung function failed to meet diagnostic criteria for COPD. Current spirometry-based diagnostic methods are not the best predictors of COPD progression and death. CT indicated emphysema and airway inflammation were recognized as better predictors of disease progression and mortality. Based on a large cohort study, some scholars proposed the concept of early COPD, focusing on people under the age of 50, smoking for more than 10 pack years, having one of the manifestations of early airflow limitation, abnormal chest CT, and rapid decline of FEV1, to study the mechanism of disease progression and early intervention methods.\[4\] In this study, we enroll participants with early COPD symptoms, to detect the progression of COPD with 3 years of follow-up. The predictors of disease progression and variants of bioactive molecular were analyzed, so as to clarify the progressive mechanism of COPD.

Interventions

None listed

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* 1\. \<60 years old; 2\. Smoking ≥ 10 pack years. 3\. With any of the following anomalies: a. Post-bronchodilator FEV1/FVC\< 0.7. b. CT image abnormalities: emphysema, air trapping or bronchial wall thickening; c.Rapid decrease of FEV1 (\>60 ml/yr).

Exclusion criteria

* 1\. With other known chronic lung diseases, including bronchiectasis, interstitial pulmonary disease, tuberculosis, and pulmonary vascular disease (CTEPH). 2\. With severe pleural disease and/or lesions of the sternum or ribs. 3\. Suffering from serious uncontrolled other systemic diseases, including chest and abdominal surgery, heart attack (angina pectoris, myocardial infarction, malignant arrhythmia, etc.) and cerebrovascular disease (stroke) within 3 months, as well as kidney disease (AKI), cirrhosis, and any malignant tumor except lung cancer. 4\. Suffering from severe cognitive impairment. 5\. With active tuberculosis or are taking anti-tuberculosis treatment. 6\. Pregnancy or lactation. 7\. Previous lung surgery. 8\. Acute upper and lower respiratory system infection within 4 weeks.

Design outcomes

Primary

MeasureTime frameDescription
lung functionLung function will be tested at the 1st year, the 2nd year and the 3rd year.Patients' lung function will be tested to identify air flow decrease in the early COPD group and the control group.

Secondary

MeasureTime frameDescription
Blood samplesThe 1st year and the 3rd year of follow-upCollect venous blood to detect cytokines and other molecular.
CTThe 1st year and the 3rd year of follow-upBoth inspiration phase and expiration phase are required
Exhaled breath condensateThe 1st year and the 3rd yearUsing commercially available exhaled breath condensate collection
Exhaled hydrogen sulfide and nitric oxideThe 1st year and the 3rd yearUsing breath analyzer to detect real-time release
Pulmonary tissueThe 1st year patients are enrolledPulmonary tissue will be obtained from patients who are about to undergo resection, for example, COPD patients with lung cancer.

Countries

China

Contacts

Primary ContactYahong Chen, PHD
chenyahong@vip.sina.com+8601082266699

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026